Bleeding disorders:
Indications for OCTAGAM 10%:
Chronic immune thrombocytopenic purpura (ITP).
Adult:
Individualize. Total dose of 2g/kg, divided into 2 doses of 1g/kg (10mL/kg) given on 2 consecutive days by IV infusion at a rate of 1mg/kg/min, if tolerated may increase at 30min intervals to 2mg/kg/min, then 4mg/kg/min, then 8mg/kg/min, then up to max 12mg/kg/min. Risk of renal dysfunction/failure or thrombosis: give at the minimum practicable infusion rate; max: <3.3mg/kg/min. See full labeling.
Children:
Not established.
Contraindications:
IgA deficiency with antibodies against IgA. Previous severe reaction to human immune globulin.
Boxed Warning:
Thrombosis. Renal dysfunction and acute renal failure.
Warnings/Precautions:
Advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, cardiovascular risk factors: increased risk of thrombosis. Monitor for signs/symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Ensure adequate hydration. Pre-existing renal insufficiency, diabetes, >65yrs, hypovolemia, sepsis, paraproteinemia: increased risk of renal dysfunction or acute renal failure. Correct volume depletion; assess renal function, BUN, serum creatinine, urine output before and during therapy; discontinue if renal function deteriorates. Corn allergy. Discontinue if hypersensitivity reactions occur; have epinephrine available. Monitor for aseptic meningitis, hemolysis and delayed hemolytic anemia; consider measuring baseline hemoglobin or hematocrit and approx. 36–96hrs post-infusion if patients are high risk. Monitor for pulmonary dysfunction; perform test for anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) suspected. Antibody formation. Risk of transmission of blood-borne diseases. Elderly. Pregnancy (Cat.C). Nursing mothers.
Pharmacologic Class:
Immune globulin.
Interactions:
Avoid live viral vaccines for ≥3 months. Concomitant nephrotoxic drugs: increased risk of acute renal failure. Falsely elevated results with some blood glucose tests (eg, GDH-PQQ based or glucose-dye-oxidoreductase methods); use glucose-specific method only.
Adverse Reactions:
Headache, fever, increased heart rate; renal dysfunction (may be fatal), hyperproteinemia, increased serum viscosity, hyponatremia; rare: hemolytic anemia, aseptic meningitis syndrome (esp. with high doses or rapid infusion), TRALI, thrombosis.
How Supplied:
Single-use bottle—1
